Indevus Sanctura XR To Begin Phase III Trials “Shortly”
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm targets second half of 2006 for NDA submission for the extended-release formulation of the overactive bladder treatment. Sanctura maintains 3% share of new prescriptions in the quarter despite heavy promotion from competitors.
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Indevus expects to begin Phase III trials for an extended-release formulation of its urinary incontinence treatment Sanctura (trospium) by the end of the summer, the firm reported during an Aug. 9 earnings call. Indevus is targeting the second half of 2006 for an NDA submission, in preparation for a 2007 launch. The once-daily, extended-release Sanctura XR demonstrated similar efficacy to twice-daily Sanctura in a pilot Phase II study, according to recently released results. Indevus' co-promotion agreement with Esprit Pharma, announced last month, will cover Sanctura XR as well as Sanctura (1 (Also see "Sanctura Co-Promotion Deal" - Pink Sheet, 11 Jul, 2005.)). Esprit acquired the marketing rights from Pliva. Esprit will contribute a total of $45 mil. to the Sanctura XR program, comprising development, NDA filing and approval milestones. The nearest milestone payment is $10 mil. upon the initiation of Phase III trials. Under the agreement, Indevus expects to receive in excess of $100 mil. in milestone payments, royalties and sales force reimbursements from Esprit over the following three years. "The royalty rates have been increased and the threshold tiers in order to achieve those royalties have been lowered" compared to Indevus' previous agreement with Pliva, CFO Michael Rogers explained. Sanctura was able to maintain its 3% share of new prescriptions in the overactive bladder market during the quarter despite heavy competition, including the launches of GlaxoSmithKline/Astellas' Vesicare (solifenacin) and Novartis' Enablex (darifenacin). New Sanctura prescriptions increased 8% while total prescriptions increased 25%. The overall OAB market also grew during the quarter, with new prescriptions up 4.1% and total prescriptions up 3.6%, Indevus reported. "Despite the impact of the heavy promotion, our share with the key segments of the OAB market has stayed fairly consistent," Exec VP and Chief Sales & Marketing Officer John Tucker said. Indevus' consolidated net revenues increased 84% year over year to $8.2 mil. in the third quarter. The firm reported a net loss of $9.8 mil. compared to a loss of $16.9 mil. in the prior-year period. - Daniel Healey |